News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The new Centre for Cell Manufacturing Ireland (CCMI) in Galway means Ireland-based scientists will be able to manufacture culture-expanded stem cells for drug research for the first time.
GSK has unveiled designs for the £350m ($587m) biomanufacturing plant it intends to build in UK and confirmed that construction will start early next year.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
Cobra says it will no longer need to rely on third-parties for its biologics quality control tests after receiving an extension to its GMP certification at a Swedish facility.